Project Manager 2 - Process Engineering

The Fountain Group; Raritan (NJ); On-site; USD 120,000 - 144,000; Full time

Job summary

The Fountain Group is seeking a Senior Material Excellence Engineer, Site MSAT in Raritan, NJ to lead global dual-sourcing for LV manufacturing materials and drive process improvements. You will manage programs, qualify vendors, and ensure cGMP compliance across sites, collaborating with manufacturing, supply chain, and leadership to deliver robust materials supply and cost efficiencies.

Requirements include a BS in a relevant discipline, 5+ years in pharma/biotech, and 3+ years of project

Qualifications

• Bachelor's degree in Biochemistry, Biotechnology, Chemical Engineering, or a related discipline.
• 5+ years of pharmaceutical or biotechnology industry experience.
• 3+ years of project management experience.
• Experience with viral manufacturing (lentiviral vector) is preferred.
• Familiarity with cGMP, FDA/EMA regulations, and change control processes.
• Knowledge of URS, vendor qualification, and material specifications.

Responsibilities

• Lead global dual-sourcing initiatives for LV manufacturing materials.
• Drive process improvement for material reliability and cost reduction.
• Develop and manage project plans, milestones, and schedules.
• Identify materials and vendors; prepare URS for qualification.
• Review vendor drawings; support material comparability assessments.
• Define material quality attributes and change controls.
• Analyze manufacturing performance to improve process robustness.
• Conduct risk assessments and mitigation strategies.
• Implement processes for supply chain, logistics, and distribution.
• Coordinate MSAT activities with stakeholders across sites.
• Ensure operations comply with cGMP and health authority requirements.

Skills

Pharma/biotech industry experience

Project management

GMP/regulatory knowledge

Vendor qualification support

Material sourcing

Risk assessment

Supply chain/process improvement

cGMP compliance

Process robustness

URS development

Lentiviral vector knowledge

Education

Bachelor's degree in Biochemistry / Biotechnology / Chemical Engineering

Job description

Senior Material Excellence Engineer, Site MSAT

Location: Raritan, NJ
Pay Rate: $63.54/hour
Duration: 1 year

Job Description

• Lead global dual-sourcing initiatives for lentiviral vector (LV) manufacturing materials under Project S.U.R.G.E.
• Lead process improvement projects focused on material reliability, supply resilience, manufacturing performance, and cost reduction.
• Develop and manage project plans, milestones, deliverables, and critical-path schedules for material dual-sourcing programs.
• Identify materials and vendors and develop URS documentation to support vendor qualification and sourcing activities.
• Conduct technical reviews of vendor drawings and support formal material comparability assessments.
• Define material quality attributes and implement associated change controls.
• Analyze manufacturing performance and develop initiatives to improve process robustness and operational efficiency.
• Conduct risk assessments and develop appropriate mitigation strategies.
• Implement processes supporting supply chain, logistics, and material distribution.
• Develop project analytics, schedules, and visual management tools to track key handoffs and transitions.
• Coordinate site and global MSAT activities with manufacturing, production, supply chain, vendors, and leadership stakeholders.
• Support pharmaceutical manufacturing operations in compliance with cGMP and applicable health authority requirements.

Education

• Bachelor's degree in Biochemistry, Biotechnology, Chemical Engineering, or a related scientific/engineering discipline required.

Required Skills

• 5+ years of pharmaceutical or biotechnology industry experience.
• 3+ years of project management experience.
• Pharmaceutical/biotechnology manufacturing experience.
• Biological manufacturing processes, including upstream and downstream processing.
• Lentiviral vector or viral manufacturing knowledge.
• cGMP guidelines and pharmaceutical regulatory requirements, including FDA and EMA.
• Material specifications and quality attributes.
• User Requirements Specifications (URS).
• Change control development and implementation.
• Material comparability assessments.
• Vendor technical evaluation and qualification support.
• Manufacturing process improvement and process robustness.
• Risk assessment and mitigation.
• Supply chain, logistics, and material distribution processes.